Xerostomia in Sjogrens syndrome
Conditions
Interventions
Rebamipide was administered orally at 100 mg each time three times a day after meals for 8 weeks.
Placebo was administered orally three times a day after meals for 8 weeks.
Sponsors
Tochigi medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients was given Cevimeline hydrochloride hydrate or oral pilocarpine more than one year. However,the effect was insufficient. Patients who could come to the outpatient clinic for at least 12 weeks. Patients with a salivary flow rate of not more than 10 mL for 10 min in the chewing gum test and having subjective symptoms of xerostomia. The person who gets mutual understanding. Patients with white cell and platelet count judged to be normal.
Exclusion criteria
Exclusion criteria: Patients with a history of treatment or currently on treatment for facial or trigeminal neuropathy. Patients with a history of treatment or currently on treatment salivary gland disorders other than SS within 6 months before start of administration. Patients with diabetes. Patients with hypersensitivity to rebamipide. Patients now taking or who took within one month previously rebamipide. Patients taking other drug for the treatment of gastritis and gastric ulcer. Patients who have or might have upper digestive tract, hepatic or biliary disease. Patients with severe hepatic dysfunction or renal dysfunction. Women who are pregnant or who might be pregnant or lactating mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of increase in the unstimulated whole saliva secretion after administration 8W | — |
Countries
Japan
Contacts
Public ContactHiroshi Iwabuchi
Tochigi medical center Department of Dentistry and Oral Surgery
Outcome results
None listed